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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, bed patient
Product CodeKMI
Regulation Number 880.2400
Device Class 1


Premarket Reviews
ManufacturerDecision
AFRAME DIGITAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTAURI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEL-GE CARE INNOVATIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
LEAF HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WIRELESS MEDCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 358 358
2015 34 34
2016 24 24
2017 30 30
2018 28 28
2019 14 14
2020 17 17
2021 14 14
2022 21 21
2023 35 35
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 174 174
No Audible Alarm 96 96
Device Operates Differently Than Expected 28 28
Loose or Intermittent Connection 26 26
Loss of Power 18 18
Defective Alarm 16 16
Insufficient Information 16 16
Failure to Power Up 15 15
Improper Alarm 15 15
Fitting Problem 15 15
False Alarm 13 13
Break 13 13
Device Issue 12 12
Device Stops Intermittently 11 11
Delayed Alarm 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Component Missing 8 8
Device Displays Incorrect Message 8 8
Component Falling 7 7
Device Slipped 6 6
Device Inoperable 6 6
Battery Problem 6 6
Communication or Transmission Problem 6 6
Connection Problem 6 6
Device Operational Issue 6 6
Device Sensing Problem 5 5
Power Problem 5 5
Inaudible or Unclear Audible Prompt/Feedback 5 5
Failure to Sense 5 5
Alarm Not Visible 4 4
Defective Device 4 4
Fail-Safe Problem 4 4
Device Damaged Prior to Use 3 3
Defective Component 3 3
Improper or Incorrect Procedure or Method 3 3
Intermittent Continuity 3 3
Appropriate Term/Code Not Available 3 3
Detachment Of Device Component 2 2
Smoking 2 2
Unstable 2 2
Use of Device Problem 2 2
Mechanical Problem 2 2
Device Emits Odor 2 2
No Audible Prompt/Feedback 2 2
Patient Device Interaction Problem 2 2
Device Fell 1 1
Intermittent Loss of Power 1 1
Excessive Heating 1 1
Intermittent Communication Failure 1 1
Physical Property Issue 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Detachment of Device or Device Component 1 1
Inappropriate or Unexpected Reset 1 1
Unknown (for use when the device problem is not known) 1 1
Visual Prompts will not Clear 1 1
Invalid Sensing 1 1
Incorrect Or Inadequate Test Results 1 1
Decreased Sensitivity 1 1
Biocompatibility 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
No Device Output 1 1
Overheating of Device 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Self-Activation or Keying 1 1
Under-Sensing 1 1
Sticking 1 1
Computer Software Problem 1 1
Crack 1 1
Disconnection 1 1
Electrical /Electronic Property Problem 1 1
Premature Discharge of Battery 1 1
Bent 1 1
Low Audible Alarm 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 164 164
No Known Impact Or Consequence To Patient 156 156
Fall 86 87
No Patient Involvement 84 84
No Clinical Signs, Symptoms or Conditions 47 47
Bone Fracture(s) 11 11
Not Applicable 10 10
Insufficient Information 9 9
Head Injury 7 7
Injury 6 6
Hip Fracture 6 6
Skin Tears 5 5
No Information 5 5
No Patient involvement 3 3
Hemorrhage/Bleeding 3 3
Pain 3 3
Intracranial Hemorrhage 2 2
Hemorrhage, Subarachnoid 2 2
Hematoma 2 2
Abrasion 2 2
Bruise/Contusion 2 2
Contusion 2 2
Death 2 2
Pressure Sores 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 1 1
Unspecified Gastrointestinal Problem 1 1
Blister 1 1
Localized Skin Lesion 1 1
Anxiety 1 1
Distress 1 1
Discomfort 1 1
Fracture, Arm 1 1
Depression 1 1
Loss of consciousness 1 1
Suture Abrasion 1 1
Superficial (First Degree) Burn 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
Blood Loss 1 1
Facial Nerve Paralysis 1 1
Cardiac Arrest 1 1
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Peeling 1 1
Swelling 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AliMed Corporation II Apr-16-2010
2 Curbell Medical, Inc. II Aug-26-2014
3 Hill-Rom Inc. II Mar-22-2020
4 Intel-GE Care Innovations LLC II Feb-23-2013
5 RF Technologies, Inc. II Jun-26-2013
6 Richard Wolf Medical Instruments Corp. II Mar-03-2015
7 Stanley Security Solutions Inc II May-15-2019
8 Stanley Security Solutions, Inc. II Sep-28-2012
9 Stanley Security Solutions, Inc. II Apr-28-2012
10 Stanley Security Solutions, Inc. II Apr-27-2012
11 Stanley Security Solutions, Inc. II Mar-31-2011
12 Stanley Security Solutions, Inc. II Jul-01-2010
13 Sterilmed Inc II Jan-13-2009
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